Regulatory approval (chapter 6) of a biosimilar is granted on the basis that its efficacy and safety have been demonstrated as equivalent to those of the reference biopharmaceutical. It is also accepted that biosimilars are not completely identical to the reference product – differences in their respective manufacturing processes (chapter 2) may lead to minor variations between biosimilars and their reference biopharmaceutical in some clinical properties, for example, their immunogenic potential.
Pre-approval, phase 3 clinical trials of biosimilar drugs conducted to establish safety and efficacy are not in general designed to predict whether, for example, post-translational modifications related to manufacturing conditions (chapter 1). Because a biosimilar is essentially the same as the reference product, any differences in its clinical performance leading to practice-related adverse effects may be rare occurrences, only detectable after prolonged exposure in many people.
In this chapter, we discuss pharmacovigilance in the context of biologics and biosimilars and ensuring traceability.
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